Puma Biotechnology Inc (PBYI) 2025 Q2 法說會逐字稿

Good afternoon. My name is Latanya, and I will be your conference call operator today. (Operator Instructions) As a reminder, this call is being recorded.

午安.我叫拉塔尼亞 (Latanya)，今天我將擔任您的電話會議接線生。（操作員指示）提醒一下，此通話正在被錄音。

I would now like to turn the conference over to your host today, Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

現在，我想將會議交給今天的主持人，Puma Biotechnology IR 高級總監 Mariann Ohanesian。您可以開始您的會議了。

Thank you, Latanya. Good afternoon and welcome to Puma's conference call to discuss our earnings results for the second quarter of 2025. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaber, Senior Vice President of Marketing; and Roger Storms, Senior Vice President of Sales.

謝謝你，拉塔尼亞。下午好，歡迎參加 Puma 電話會議，討論我們 2025 年第二季的獲利結果。今天與我一起參加電話會議的還有 Puma Biotechnology 執行長、總裁兼董事會主席 Alan Auerbach、財務長 Maximo Nougues、行銷資深副總裁 Heather Blaber 和銷售資深副總裁 Roger Storms。

After the close today, Puma issued a news release detailing earnings results for second-quarter 2025. That news release, the slides that Roger will refer to, and a webcast of this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

今天收盤後，彪馬發布了一份新聞稿，詳細介紹了 2025 年第二季的獲利結果。新聞稿、Roger 將要引用的幻燈片以及本次電話會議的網路直播均可透過我們網站 pumabiotechnology.com 的主頁和投資者專區存取。網路直播和簡報投影片將存檔於我們的網站上，並可在接下來的 90 天內重播。

Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, August 7, 2025. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call except as required by law.

今天的電話會議將包括有關彪馬未來預期、計劃和前景的聲明，這些聲明構成聯邦證券法所指的前瞻性聲明。此類聲明受風險和不確定性的影響，實際事件和結果可能與這些前瞻性聲明中表達的不同。要全面了解這些風險和不確定性，請查看我們不時向美國證券交易委員會提交的定期報告和當前報告，包括截至 2024 年 12 月 31 日的 10-K 表格年度報告。請注意不要過度依賴這些前瞻性陳述，這些陳述僅代表截至本次現場電話會議召開之日（2025 年 8 月 7 日）的觀點。除非法律要求，否則彪馬不承擔修改或更新任何前瞻性聲明以反映本次電話會議日期之後的事件或情況的義務。

During today's call we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our second-quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results.

在今天的電話會議中，我們可能會參考某些涉及調整我們的 GAAP 數據的非 GAAP 財務指標。我們認為，這些非公認會計準則指標可能對投資人有用，可以作為我們公認會計準則財務指標的補充，但不能取代。請參閱我們的 2025 年第二季財報，以了解我們的 GAAP 與非 GAAP 結果的對照組。

I will now turn the call over to Alan.

現在我將電話轉給艾倫。

Thank you, Mariann, and thank you all for joining our call today.

謝謝你，瑪麗安，也謝謝大家今天參加我們的電話會議。

Today, Puma reported total revenue for the second quarter of 2025 of $52.3 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sublicensees. Product revenue net was $49.2 million in the second quarter of 2025, an increase from $43.1 million reported in Q1 2025, and an increase from $44.4 million reported in Q2 2024.

今天，彪馬公佈 2025 年第二季總收入為 5,230 萬美元。總收入包括產品淨收入，其中完全由 NERLYNX 銷售額以及來自我們的再授權商的特許權使用費組成。2025 年第二季產品淨收入為 4,920 萬美元，高於 2025 年第一季的 4,310 萬美元，也高於 2024 年第二季的 4,440 萬美元。

Product revenue for the second quarter of 2025 was impacted by approximately $1.3 million of inventory decrease at our specialty pharmacies and specialty distributors. Royalty revenue was $3.2 million in the second quarter of 2025 compared to $2.9 million in Q1 2025 and $2.7 million in Q2 2024. We reported 2,608 bottles of NERLYNX sold in the second quarter of 2025, an increase of 270 from the 2,338 bottles sold in Q1 2025. In Q2 2025, we estimate that inventory decreased by 72 bottles.

2025 年第二季的產品收入受到我們專業藥局和專業經銷商庫存減少約 130 萬美元的影響。2025 年第二季特許權使用費收入為 320 萬美元，而 2025 年第一季為 290 萬美元，2024 年第二季為 270 萬美元。我們報告稱，2025 年第二季售出了 2,608 瓶 NERLYNX，比 2025 年第一季售出的 2,338 瓶增加了 270 瓶。2025年第二季度，我們估計庫存減少了72瓶。

In Q2 2025, new prescriptions were down approximately 3% compared to Q1 2025, and total prescriptions were up approximately 3% compared to Q1 2025. Roger will provide further details in his comments and slides. I will now provide a clinical review of the quarter. Then Heather Blaber and Roger Storms will add additional color on NERLYNX's commercial activities. Maximo Noguez will follow with highlights of the key components of our financial statements for the second quarter of 2025.

2025 年第二季度，新處方與 2025 年第一季相比下降了約 3%，總處方與 2025 年第一季相比增加了約 3%。羅傑將在他的評論和幻燈片中提供更多細節。我現在將對本季度進行臨床回顧。隨後，Heather Blaber 和 Roger Storms 將為 NERLYNX 的商業活動增添更多色彩。Maximo Noguez 將重點介紹我們 2025 年第二季財務報表的關鍵部分。

As investors are aware, Puma currently has two ongoing Phase II trials of our investigational drug alisertib. One is ALISCA-Breast1, which is a Phase II trial of alisertib in combination with endocrine treatment in patients with HER2-negative, hormone receptor-positive metastatic breast cancer. And the second is ALISCA-Lung1, which is a Phase II study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer.

正如投資者所知，Puma 目前正對我們的研究藥物 alisertib 進行兩項 II 期試驗。一項是ALISCA-Breast1，這是一項針對HER2陰性、荷爾蒙受體陽性轉移性乳癌患者進行alisertib聯合內分泌治療的II期試驗。第二項是 ALISCA-Lung1，這是一項 II 期研究，旨在研究阿利塞蒂佈單藥治療小細胞肺癌患者的療效。

As a reminder, the ALISCA-Breast1 investigates alisertib in combination with endocrine treatment, which consists of either anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen in patients with HER2-negative, hormone receptor-positive metastatic breast cancer. Patients must be chemotherapy-naive, must have previously received treatment with a CDK4/6 inhibitor, and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients are being dosed with alisertib either at 30 milligrams, 40 milligrams, or 50 milligrams twice daily, BID, on days 1 to 3, 8 to 10, and 15 to 17 on a 28-day cycle in combination with endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine therapy in the metastatic setting that is being given in combination with alisertib in the trial.

提醒一下，ALISCA-Breast1 研究了 alisertib 與內分泌治療的聯合作用，內分泌治療包括阿那曲唑、依西美坦、來曲唑、氟維司群或他莫昔芬，用於治療 HER2 陰性、激素受體陽性的轉移性乳腺癌患者。患者必須未接受過化療，必須之前接受過 CDK4/6 抑制劑治療，並且在復發或轉移的情況下接受過至少兩種內分泌治療才有資格參加試驗。患者每天服用兩次 30 毫克、40 毫克或 50 毫克的 alisertib，BID，在 28 天的周期內，第 1 至 3 天、第 8 至 10 天和第 15 至 17 天，並結合研究者選擇的內分泌療法。患者之前不得接受過與試驗中的 alisertib 合併進行的轉移性內分泌治療。

Primary efficacy endpoints include objective response rate, duration of response, disease control rate, and progression-free survival. As a secondary objective, the company will be evaluating each of these efficacy biomarkers within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy, as has been seen in preclinical and clinical studies in other cancers, including breast and small cell lung cancer. The company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive breast cancer within these biomarkers.

主要療效終點包括客觀緩解率、緩解持續時間、疾病控制率和無惡化存活期。作為次要目標，該公司將評估生物標記亞組中的每個功效生物標記物，以確定任何生物標記亞群是否與更好的功效相關，正如在其他癌症（包括乳腺癌和小細胞肺癌）的臨床前和臨床研究中所看到的那樣。該公司將重點關注 alisertib 與內分泌療法聯合治療這些生物標記內的 HER2 陰性、荷爾蒙受體陽性乳癌患者的未來臨床開發。

The trial was initiated in late November 2024. There are currently 33 sites in the US and 18 sites in Europe that have been activated for the trial, and the trial is enrolling ahead of expectations. There are currently 62 patients enrolled in the trial and 10 additional patients in screening. We are looking to have interim data from this trial later in 2025.

該試驗於2024年11月下旬啟動。目前美國已有 33 個地點、歐洲已有 18 個地點啟動該試驗，試驗招募工作正在超越預期。目前共有 62 名患者參加試驗，另有 10 名患者正在接受篩選。我們希望在 2025 年稍後獲得該試驗的中期數據。

With respect to ALISCA-Lung1, as investors are aware, Puma has an ongoing Phase II trial of our investigational drug alisertib to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer and specifically look at the efficacy of the drug in patients with biomarkers where the Aurora kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA 1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in The Journal of Thoracic Oncology in 2020.

關於 ALISCA-Lung1，正如投資者所知，Puma 正在對我們的研究藥物 alisertib 進行 II 期試驗，以研究 alisertib 單一療法對小細胞肺癌患者的療效，特別是觀察該藥物對具有 Aurora 激酶通路發揮作用的生物標誌物的患者的療效。目標是將 ALISCA 1 研究中這些生物標記亞群的療效與 2020 年發表在《胸腔腫瘤學雜誌》上的紫杉醇聯合阿利塞蒂布對比紫杉醇聯合安慰劑隨機試驗中生物標誌物亞組的療效關聯起來。

In that randomized trial, a progression-free survival and overall survival benefit were seen in patients with biomarkers that correlate with the Aurora kinase pathway. If the efficacy and biomarker data are comparable from the two studies, the company would look to engage with the FDA to discuss the regulatory path further. As discussed on the recent earnings call, the company believes that the data obtained to date from ALISCA-Lung1 is providing a preliminary indication of potentially better activity in patients with biomarkers where the Aurora kinase pathway plays a role. The most recent analysis of the pharmacokinetic data from ALISCA-Lung1 study suggests that we are seeing a lower PK of alisertib in the ALISCA 1 trial compared with the previous Phase II study of alisertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology.

在該隨機試驗中，在具有與 Aurora 激酶路徑相關的生物標記的患者中觀察到無進展生存期和總體生存期獲益。如果兩項研究的療效和生物標記數據具有可比性，該公司將尋求與 FDA 合作進一步討論監管途徑。正如最近的收益電話會議上所討論的那樣，該公司認為，迄今為止從 ALISCA-Lung1 獲得的數據初步表明，在 Aurora 激酶通路發揮作用的生物標誌物患者中，其活性可能會更好。ALISCA-Lung1 研究的藥物動力學數據的最新分析表明，與先前在《柳葉刀腫瘤學》上發表的針對小細胞肺癌患者進行 alisertib 單藥治療的 II 期研究相比，我們在 ALISCA 1 試驗中看到的 alisertib 的 PK 較低。

The company has amended the protocol for the trial to increase the dose of alisertib from 50 milligrams BID to 60 milligrams BID, which the company believes will increase the PK of the drug to levels closer to that of what was seen in the prior Phase II trial. The company is currently enrolling patients at the 60 milligrams BID dose. There are currently 52 patients enrolled in the trial with an additional three patients in screening. The company looks to have additional interim data from the trial later in 2025.

該公司已經修改了試驗方案，將 alisertib 的劑量從 50 毫克 BID 增加到 60 毫克 BID，該公司認為這將使該藥物的 PK 水平更接近先前 II 期試驗的水平。該公司目前正在招募每日兩次、每次 60 毫克劑量的患者。目前共有 52 名患者參加試驗，另有 3 名患者正在接受篩選。該公司希望在 2025 年稍後獲得該試驗的更多中期數據。

As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-license or acquire that allow the company to diversify itself and leverage Puma's existing R&D, regulatory, and commercial infrastructure. The company will keep investors updated on this as it progresses.

正如在先前的收益電話會議和回答投資者問題時所提到的，Puma 繼續評估幾種可能獲得許可或收購的藥物，以使公司實現多元化，並利用 Puma 現有的研發、監管和商業基礎設施。公司將向投資者通報此事的進展。

I will now turn the call over to Heather Blaber for an update on our marketing initiatives, and Roger Storms will follow with a review of our commercial performance during the quarter.

現在，我將把電話轉給 Heather Blaber，以了解我們的行銷計劃的最新情況，隨後 Roger Storms 將回顧我們本季的商業表現。

Thank you, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on creating awareness of both clinical messaging for NERLYNX, as well as recently published data that demonstrate the continued need to reduce the risk of recurrence in HER2-positive early breast cancer after completion of adjuvant therapy. We continue to invest in market research to help us better understand risk factors that put a patient at high risk of recurrence in HER2-positive early-stage breast cancer, as well as garner insights on the clinical data in this patient population.

謝謝你，艾倫。我很高興有機會分享一些有關我們行銷策略的額外見解。行銷團隊致力於提高人們對 NERLYNX 臨床資訊的認識，以及最近發布的數據，這些數據表明在完成輔助治療後仍需要降低 HER2 陽性早期乳癌的復發風險。我們持續投資於市場研究，以幫助我們更好地了解導致 HER2 陽性早期乳癌患者復發風險較高的風險因素，並深入了解該患者群體的臨床數據。

Together with our marketing initiatives, our strategy is focused on increasing awareness of our broad indication of patients that are appropriate for treatment with NERLYNX.

結合我們的行銷舉措，我們的策略重點是提高患者對適合使用 NERLYNX 治療的廣泛適應症的認識。

Based on our insights, we have adjusted our strategy on key learnings and revised both personal and non-personal messaging with the goal of engaging physicians on a broader set of patients where the risk of recurrence remains high and where we believe NERLYNX can play an important role in helping to reduce the risk of recurrence in patients with early-stage HER2-positive breast cancer. In addition to revising our messaging, we recently rolled out a new resource to support patients throughout their recommended course of NERLYNX therapy. This educational resource will be provided to patients on a monthly basis as they receive their refills.

根據我們的見解，我們調整了關鍵學習策略，並修改了個人和非個人信息，目的是讓醫生參與更廣泛的患者群體，這些患者的複發風險仍然很高，我們相信 NERLYNX 可以在幫助降低早期 HER2 陽性乳腺癌患者的複發風險方面發揮重要作用。除了修改我們的訊息傳遞方式外，我們最近還推出了一項新資源，為患者在整個推薦的 NERLYNX 治療過程中提供支援。當患者收到補充藥物時，我們將每月向他們提供此教育資源。

Lastly, year-to-date, we have reached 99.7% of oncologists through non-personal promotion and continue to expand our share of voice, working closely with the sales team to increase engagement with healthcare providers. In summary, we are excited about our new marketing strategy and messaging, which we believe will continue to help educate and engage oncologists on the unmet need for those diagnosed with HER2-positive early-stage breast cancer.

最後，年初至今，我們已經透過非個人推廣接觸了 99.7% 的腫瘤學家，並繼續擴大我們的話語權，與銷售團隊密切合作，以增加與醫療保健提供者的互動。總而言之，我們對新的行銷策略和訊息傳遞感到非常興奮，我們相信這將繼續幫助教育和吸引腫瘤學家關注那些被診斷為 HER2 陽性早期乳癌患者的未滿足需求。

I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the second quarter.

現在我將把電話轉給羅傑·斯托姆斯 (Roger Storms)，讓他概述第二季的商業表現。

Thank you, Heather, and thanks to everyone for joining our second-quarter earnings call. But before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team continues to work hard on expanding overall HCP reach and frequency with an emphasis on increasing engagement when treatment decisions are being made. Q2 2025 call activity was up 16% year over year and up 24% quarter over quarter.

謝謝你，希瑟，也謝謝大家參加我們第二季的財報電話會議。但在進入商業評論之前，我只想提醒一下，我將做出前瞻性的陳述。銷售團隊繼續努力擴大 HCP 的整體覆蓋率和頻率，重點是在製定治療決策時提高參與度。2025 年第二季的通話活動年增 16%，較上季成長 24%。

This is a direct result of being able to fill key vacancies that existed in Q1, as well as continued emphasis put on executional excellence and increased accountability in Q2 with the existing sales team. The commercial team remains focused on expanding the utilization of NERLYNX with the primary emphasis on patients who are at increased risk of recurrence. The team has continued their emphasis on improving clinical education and engagement through non-personal promotion as well as using the patient resource brochure designed to improve persistence and compliance throughout their NERLYNX therapy. Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance.

這是能夠填補第一季存在的關鍵空缺的直接結果，也是第二季度繼續強調執行卓越性和增加現有銷售團隊的責任的結果。商業團隊仍致力於擴大 NERLYNX 的使用率，主要關注復發風險較高的患者。團隊繼續強調透過非個人推廣來改善臨床教育和參與度，以及使用旨在提高整個 NERLYNX 治療過程中的持久性和依從性的患者資源手冊。現在讓我轉到一些商業幻燈片，我將在其中提供有關性能的一些其他細節。

Slide 3 is an illustration of our distribution model, which is broken out into the specialty pharmacy channel and the specialty distributor or in-office dispensing channel. In regards to the overall distribution of our business in Q2 '25, about 63% of our business was purchased through the SP channel, and the remaining 37% was purchased through the SD channel. We are seeing some stronger growth in the SD channel, driven by two main factors: one, increased 340B purchasing; and two, increased sales in the group purchasing organization or GPO segment.

投影片 3 說明了我們的分銷模式，該模式分為專業藥房通路和專業經銷商或辦公室配藥通路。就我們25年第二季業務的整體分佈而言，大約63％的業務是透過SP管道購買的，其餘37％是透過SD管道購買的。我們看到 SD 通路出現了更強勁的成長，主要由兩個因素推動：一是 340B 採購量增加；二是團體採購組織或 GPO 部門的銷售額增加。

Turning to slide 4. NERLYNX net product revenue in Q2 2025 was $49.2 million, which represents an increase of $6.1 million from the $43.1 million we reported in Q1 of '25 and an increase of $4.8 million from the $44.4 million we reported in Q2 of '24. I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross to net expenses during his update. In Q2 2025, we estimate that inventory decreased by about $1.3 million. As a comparator, we estimate that inventory increased by about $4.7 million in Q1 of 2025 and decreased by about $2.3 million in Q2 of 2024.

翻到幻燈片 4。NERLYNX 2025 年第二季的淨產品收入為 4,920 萬美元，比我們報告的 2025 年第一季的 4,310 萬美元增加了 610 萬美元，比我們報告的 2024 年第二季的 4,440 萬美元增加了 480 萬美元。我將提供有關庫存變化的更多細節，而 Maximo 將在更新期間提供有關總支出到淨支出的一些額外細節。2025 年第二季度，我們估計庫存減少約 130 萬美元。作為比較，我們估計 2025 年第一季庫存增加了約 470 萬美元，2024 年第二季庫存減少了約 230 萬美元。

Slide 5 shows Q2 2025 ex-factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. In Q2 2025, NERLYNX ex-factory bottle sales were 2,608, which represents an approximate 12% increase quarter over quarter and a 4% increase year over year. Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective.

幻燈片 5 顯示了 2025 年第二季出廠瓶裝銷量，並提供了同比和環比的比較。2025 年第二季度，NERLYNX 出廠瓶裝銷量為 2,608 瓶，較上季成長約 12%，較去年同期成長 4%。與之前的投影片類似，讓我從瓶子的角度具體講一下庫存變化。

In Q2 2025, we estimate that inventory decreased by 72 bottles. As a comparator, we estimate that inventory decreased by 250 bottles in Q1 of 2025 and decreased by 132 bottles in Q2 of 2024.

2025年第二季度，我們估計庫存減少了72瓶。作為比較，我們估計 2025 年第一季庫存減少了 250 瓶，2024 年第二季庫存減少了 132 瓶。

Let me take a moment to provide some additional metrics regarding our second-quarter performance. In Q2, we saw enrollments decrease about 9% quarter over quarter and decline about 11% year over year. New patient starts, or NRX, followed a similar pattern, declining approximately 3% quarter over quarter and also declining 1% year over year.

請容許我花點時間提供一些有關我們第二季業績的額外指標。在第二季度，我們發現入學人數較上季下降約 9%，年減約 11%。新患者開始數量（NRX）也呈現類似的模式，較上季下降約 3%，較去年同期下降 1%。

Turning to total prescriptions or TRX, we saw TRX increase 3% quarter over quarter and decline about 2% year over year. Finally, let me share some specifics around demand. In Q2, we saw demand increase about 4% quarter over quarter and increase about 2% year over year. As mentioned earlier, we've seen a stronger demand growth in the SD channel where we saw demand grow about 8% quarter over quarter and about 17% year over year.

談到總處方量或 TRX，我們發現 TRX 環比增長 3%，年減約 2%。最後，讓我分享一些有關需求的具體情況。在第二季度，我們看到需求較上季成長約 4%，年增約 2%。如前所述，我們看到 SD 通路的需求成長更加強勁，其需求較上季成長約 8%，較去年同期成長約 17%。

Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX's launch. In Q2, approximately 71% of patients started NERLYNX at a reduced dose. This is similar to the 72% we reported in Q1 of 2025. Continued messaging and adoption of dose escalation remains an important commercial priority.

幻燈片 6 重點介紹了自 NERLYNX 推出以來每季劑量遞增的採用情況。在第二季度，約 71% 的患者開始以降低的劑量服用 NERLYNX。這與我們在 2025 年第一季報告的 72% 相似。持續傳遞訊息和採用劑量遞增仍然是重要的商業優先事項。

Patients who are started on NERLYNX utilizing dose escalation have better persistence and compliance. We believe dose escalation, coupled with the new patient education resources, will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence.

以劑量遞增開始使用 NERLYNX 的患者俱有更好的持久性和依從性。我們相信劑量遞增加上新的病患教育資源將為患者在整個 NERLYNX 治療過程中提供更好的支持，最終幫助他們降低復發風險。

Slide 7 highlights the strategic collaborations we have formed across the globe. We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward.

投影片 7 重點介紹了我們在全球範圍內建立的策略合作關係。我們非常感謝全球合作夥伴所做的出色工作，並期待支持他們繼續取得成功。

Let me wrap up by thanking the entire Puma team for their continued passion and commitment for helping patients and their families battling breast cancer. This disease can have devastating effects, and we know more can be done and more needs to be done.

最後，我要感謝整個 Puma 團隊，感謝他們持續的熱情和承諾，幫助與乳癌作鬥爭的患者及其家人。這種疾病可能造成毀滅性的影響，我們知道可以做更多，也需要做更多。

I will now turn the call over to Maximo for a review of our financial results.

現在我將把電話轉給 Maximo 來審查我們的財務結果。

Thanks, Roger. I will begin with a brief summary of our financial results for the second quarter of 2025. Please note that I will make comparisons to Q1 2025, which we believe is a better indication of our progress as a commercial company and year-over-year comparisons. For more information, I recommend that you refer to our second-quarter 2025 10-Q, which will be filed today and includes our consolidated financial statements.

謝謝，羅傑。我將首先簡要概述我們 2025 年第二季的財務表現。請注意，我將與 2025 年第一季進行比較，我們認為這更能表明我們作為一家商業公司所取得的進展以及同比變化。欲了解更多信息，我建議您參考我們今天將提交的 2025 年第二季度 10-Q 報告，其中包含我們的合併財務報表。

For the second quarter of 2025, we reported net income based on GAAP of $5.9 million or $0.12 per share. This compares to net income in Q1 2025 of $3 million or $0.06 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $7.5 million or $0.15 per basic and diluted share for the second quarter of 2025.

2025 年第二季度，我們報告的基於 GAAP 的淨收入為 590 萬美元，即每股 0.12 美元。相比之下，2025 年第一季的淨收入為 300 萬美元或每股 0.06 美元。根據非公認會計準則 (non-GAAP)，經調整以消除股票薪酬費用的影響，我們報告 2025 年第二季度的淨收入為 750 萬美元，或每股基本收益和稀釋收益 0.15 美元。

Gross revenue from NERLYNX sales was $62.1 million in Q2 2025 and $54.4 million in Q1 2025. As Alan mentioned, net product revenue from NERLYNX sales was $49.2 million, an increase from the $43.1 million reported in Q1 2025. The increase in net revenue was driven primarily by an increase in NERLYNX bottles sold in the US and an increase in net selling price. Inventory drawdown by our distributors was approximately $1.3 million in Q2 versus a drawdown of approximately $4.7 million in Q1 2025.

2025 年第二季 NERLYNX 銷售總收入為 6,210 萬美元，2025 年第一季 NERLYNX 銷售總收入為 5,440 萬美元。正如艾倫所提到的，NERLYNX 銷售的淨產品收入為 4,920 萬美元，高於 2025 年第一季報告的 4,310 萬美元。淨收入的成長主要得益於美國銷售的 NERLYNX 瓶裝產品的增加以及淨售價的上漲。我們的經銷商的庫存減少量在第二季約為 130 萬美元，而 2025 年第一季的庫存減少量約為 470 萬美元。

Royalty revenue totaled $3.2 million in the second quarter of 2025 compared to $2.9 million in Q1 2025. Our gross to net adjustment in Q2 2025 was 20.8%, unchanged from Q1 2025. Cost of sales for Q2 2025 increased to $12.3 million and includes $2.4 million for the amortization of intangible assets related to our NERLYNX (neratinib) license. Cost of sales for Q1 2025 was $10.6 million. Going forward, we will continue to recognize amortization of the milestone to the licensor of about $2.4 million per quarter as cost of sales.

2025 年第二季特許權使用費收入總計 320 萬美元，而 2025 年第一季為 290 萬美元。2025 年第二季的總淨調整率為 20.8%，與 2025 年第一季相比沒有變化。2025 年第二季的銷售成本增加至 1,230 萬美元，其中包括與我們的 NERLYNX（neratinib）授權相關的無形資產攤銷 240 萬美元。2025 年第一季的銷售成本為 1,060 萬美元。展望未來，我們將繼續將里程碑攤銷確認為每季約 240 萬美元的授權人銷售成本。

For fiscal year 2025, Puma anticipates that the net product revenue will be in the range of $192 million to $198 million. We also anticipate that our gross to net adjustment for the full year 2025 will be between 21.5% and 22%, higher than prior guidance due to an increase in government chargeback expenses.

對於 2025 財年，彪馬預計淨產品收入將在 1.92 億美元至 1.98 億美元之間。我們也預計，由於政府退款費用的增加，2025 年全年的總淨調整金額將在 21.5% 至 22% 之間，高於先前的預期。

In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 million to $24 million, lower than 2024 due to fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of 2025. We do not expect license revenue in 2025. We also expect that net income for the full year will be in the range of $23 million to $28 million.

此外，在 2025 財年，我們預計從世界各地的合作夥伴處獲得的特許權使用費將在 2000 萬美元至 2400 萬美元之間，低於 2024 年，原因是由於我們的合作夥伴在 2025 年前幾個季度經歷監管過渡，預計對中國的出貨量將減少。我們預計 2025 年不會有授權收入。我們也預計全年淨收入將在 2,300 萬美元至 2,800 萬美元之間。

We are not forecasting any potential release of any additional tax asset valuation allowance in our net income estimate at this time. However, this will be evaluated on an ongoing basis. We will continue to keep investors updated on this as it progresses.

目前，我們並未預測在淨收入估算中會釋放任何額外的稅務資產估值準備金。然而，我們將持續對此進行評估。我們將繼續向投資者通報此事的進展。

At this time, we do not believe that the tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or results of operations. However, shifting trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid to high single-digit percentage of our total cost of goods sold.

目前，我們認為美國徵收或提議徵收的關稅，特別是對其他國家徵收的關稅，不會對我們的產品成本或經營業績產生重大影響。然而，美國和其他國家的貿易政策變化迅速，難以預測。作為參考，我們的製造產品成本占我們總銷售成本的中高個位數百分比。

We anticipate that for Q3 2025, NERLYNX product revenue net will be in the range of $46 million to $48 million. Also, we expect Q3 royalty revenues will be in the range of $2 million to $3 million and no license revenue. We further estimate that the gross to net adjustment in Q3 2025 will be approximately 22.5% to 23.5%. Puma anticipates Q3 net income between $2 million and $4 million.

我們預計，2025 年第三季度，NERLYNX 產品淨收入將在 4,600 萬美元至 4,800 萬美元之間。此外，我們預計第三季特許權使用費收入將在 200 萬至 300 萬美元之間，沒有授權收入。我們進一步估計，2025 年第三季的總額與淨額調整額將約為 22.5% 至 23.5%。Puma 預計第三季淨收入將在 200 萬至 400 萬美元之間。

SG&A expenses were $18 million in the second quarter of 2025 compared to $17.6 million in the first quarter. SG&A expenses included non-cash charges for stock-based compensation of $1 million for Q2 and $1.2 million for Q1 2025.

2025 年第二季銷售、一般及行政費用為 1,800 萬美元，而第一季為 1,760 萬美元。銷售、一般及行政費用包括 2025 年第二季 100 萬美元及第一季 120 萬美元的股票薪酬非現金費用。

Research and development expenses were $15.5 million in the second quarter of 2025, an increase from the $13.8 million in the first quarter. R&D expenses included non-cash charges for stock-based compensation of $0.6 million in the second quarter of 2025 compared to $0.8 million in the first quarter.

2025 年第二季研發費用為 1,550 萬美元，高於第一季的 1,380 萬美元。研發費用包括 2025 年第二季 60 萬美元的股票薪酬非現金費用，而第一季為 80 萬美元。

On the expense side, Puma anticipates flat to slightly higher total operating expenses in 2025 compared to 2024. More specifically, we anticipate SG&A expenses to decrease by 5% to 10% and R&D expenses to increase by 20% to 25% year over year. The higher increase in R&D is driven by faster enrollments in our clinical trials than previously expected.

在費用方面，彪馬預計 2025 年的總營運費用將與 2024 年持平或略有上升。更具體地說，我們預計銷售、一般及行政費用將年減 5% 至 10%，研發費用將年增 20% 至 25%。研發費用的大幅成長是由於我們的臨床試驗報名速度比之前預期的要快。

In the second quarter of 2025, Puma reported cash earned of about $2.9 million. This compares to cash burn of approximately $7.8 million in Q1. Please note, (inaudible) Q2, we made our fifth principal loan payment of $11.1 million related to our obligation with Athyrium.

2025 年第二季度，彪馬報告現金收入約 290 萬美元。相比之下，第一季的現金消耗約為 780 萬美元。請注意，（聽不清楚）第二季度，我們支付了第五筆本金貸款 1,110 萬美元，與我們與 Athyrium 的義務有關。

As a result of this, our total outstanding principal debt balance decreased to approximately $45 million. As of June 30, 2025, we had approximately $96 million in cash, cash equivalents, and marketable securities versus about $101 million at year-end 2024. Our accounts receivable balance was $25.9 million.

因此，我們的未償還本金債務總額減少至約 4,500 萬美元。截至 2025 年 6 月 30 日，我們擁有約 9,600 萬美元的現金、現金等價物和有價證券，而 2024 年底約為 1.01 億美元。我們的應收帳款餘額為 2590 萬美元。

Our accounts receivable terms range between 10 and 68 days, while our day sales outstanding are about 50 days. We estimate that as of June 30, 2025, our distribution network maintained approximately three weeks of inventory.

我們的應收帳款期限為 10 至 68 天，而我們的未收帳款天數約為 50 天。我們估計，截至 2025 年 6 月 30 日，我們的分銷網絡維持約三週的庫存。

Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib, and controlling our expenses.

整體而言，我們將繼續部署財務資源，專注於 NERLYNX 的商業化、alisertib 的開發以及控制我們的開支。

Thanks, Maximo. Puma senior management, in cooperation with the Board of directors, continues to remain focused on NERLYNX sales trends in 2025 and beyond and recognizes its fiscal responsibility to the shareholders to continue to maintain positive net income.

謝謝，馬克西莫。Puma 高階管理層與董事會合作，繼續關注 2025 年及以後的 NERLYNX 銷售趨勢，並認識到對股東的財務責任，繼續保持正淨收入。

We are pleased to report demand-driven growth in NERLYNX sales in the first half of 2025, and we believe that the positive net income that the company achieved in Q2 2025 and the company is guiding to for the full-year 2025 resulted from the financial discipline across the company over the last three years. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet medical need for patients battling breast cancer, lung cancer, and other solid tumors.

我們很高興地報告，NERLYNX 的銷售額在 2025 年上半年實現了需求驅動的成長，我們相信，公司在 2025 年第二季度實現的正淨收入以及公司對 2025 年全年的預期得益於過去三年全公司的財務紀律。公司仍致力於繼續實現這一正淨收入，並將在必要時繼續削減開支。我們期待將來向投資者通報這一情況。對於與乳癌、肺癌和其他實體腫瘤作鬥爭的患者來說，仍然存在大量未滿足的醫療需求。

Puma are committed and passionate about finding more effective ways of helping these patients during their journey, and we will continue to strive to achieve that goal.

Puma 致力於並熱衷於尋找更有效的方法來幫助這些患者，我們將繼續努力實現這一目標。

This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

今天的演講到此結束。我們現在將把時間交還給接線員進行問答。操作員？

(Operator Instructions)

（操作員指示）

Marc Frahm, TD Cowen.

馬克·弗拉姆（Marc Frahm），TD Cowen。

Maybe on the R&D side, you mentioned two present -- two data disclosures coming up later this year. One, just the venue for that. Do you expect those to be at medical meetings or there's more likely to be corporate updates? And then maybe more importantly is, how do you view the bar there for what justifies further advancement on either side, and how does your meeting or unfortunately falling short of those bars can impact the strategic views when you talk about continuing to look at in-licensing additional products?

也許在研發方面，您提到了兩項目前的數據——今年稍後將會有兩項數據揭露。第一，只是場地而已。您是否認為這些會在醫學會議上發布，或者更有可能是公司更新？然後也許更重要的是，您如何看待雙方進一步進步的標準，以及當您談到繼續考慮授權其他產品時，您是否達到或不幸未達到這些標準會如何影響戰略觀點？

Yeah, Mark, thanks for the question. Okay, so in terms of the venue, I think we'd probably do it as a corporate update. Not sure if we do that on an earnings call or something more formal like a separate presentation to discuss it, but something in a venue. I would gauge November to December timeframe for that.

是的，馬克，謝謝你的提問。好的，就場地而言，我想我們可能會將其作為公司更新來做。不確定我們是否會在收益電話會議上或更正式的場合（例如單獨的演示）討論此事，但會在某個場合進行。我會估算 11 月至 12 月的時間範圍。

To go into a little more detail on that, on the small cell lung study, I would guess we would probably have somewhere in the neighborhood of 40-ish patients treated at 50 milligrams that we can talk about the safety, the efficacy, and the biomarkers on. We're just now enrolling at 60 milligrams, so not sure if we'd have enough data on that yet.

為了更詳細地討論小細胞肺研究，我猜想我們可能會有大約 40 名接受 50 毫克治療的患者，我們可以討論其安全性、有效性和生物標記。我們現在才開始招募 60 毫克的患者，所以不確定是否已經掌握了足夠的數據。

On the breast side, we would probably by year-end timeframe have, say, 40 to 45 patients across the three arms, so like 14 to 15 in each, and be able to discuss the safety, efficacy, and biomarkers on those. With the breast, because it's enrolling a lot faster than we expected, I think it might be a little bit of a challenge to get all the data in by year-end, that might get pushed to '26, but we'll do our best to try to deliver that.

在乳癌方面，到年底我們可能會在三個組別中擁有 40 到 45 名患者，每個組別中有 14 到 15 名患者，並且能夠討論這些患者的安全性、有效性和生物標記。對於乳癌研究，由於其招募速度比我們預期的要快得多，我認為在年底前收集所有數據可能會有點困難，可能會推遲到 26 年，但我們會盡力實現這一目標。

To answer your question in terms of development. So in terms of the path of small cell lung cancer, there was a previous study done, which was the Journal of Thoracic Oncology study, which was the randomized study of paclitaxel plus alisertib against paclitaxel plus placebo in groups that had biomarkers that were known to have a role in the Aurora kinase, looked at retrospectively, and that included like C-Met, RB1, et cetera. You did see via retrospective analysis a PFS benefit and OS benefit.

從發展的角度來回答你的問題。因此，就小細胞肺癌的路徑而言，先前有一項研究，即《胸腔腫瘤學雜誌》研究，這是一項隨機研究，比較了紫杉醇聯合阿利塞蒂布與紫杉醇聯合安慰劑，研究對象為已知在 Aurora 激酶中發揮作用的生物標誌物，並進行了回顧性研究，其中包括 C-Met、RB1 等。您確實透過回顧性分析看到了 PFS 優勢和 OS 優勢。

So our assumption always was when we bought the drug, we were only looking at it in the tumors where the Aurora kinase pathway played a role. The question we had was, were we seeing this benefit in that randomized study because alisertib had selective activity, or is that for some reason there was preclinical data that alisertib could increase the PK of paclitaxel and increase the sensitivity? Was that just what we were seeing?

因此，我們始終假設，當我們購買這種藥物時，我們只關注 Aurora 激酶路徑發揮作用的腫瘤。我們的問題是，我們在該隨機研究中看到這種益處是因為 alisertib 具有選擇性活性嗎？還是因為某種原因，有臨床前數據表明 alisertib 可以增加紫杉醇的 PK 並提高敏感性？這就是我們所看到的嗎？

So as you said, in the monotherapy study, we are indeed seeing a benefit of alisertib in the patients with biomarkers selected for the Aurora kinase pathway. To answer your question on the bar, look, you have a trial which is paclitaxel plus alisertib against paclitaxel plus placebo. Whatever that magnitude of benefit is, we would hope with the monotherapy to see a similar benefit in PFS.

正如您所說，在單一療法研究中，我們確實看到了針對 Aurora 激酶路徑選擇生物標記的患者使用 alisertib 的益處。為了回答您在酒吧的問題，您看，您有一個試驗，即紫杉醇加阿利塞蒂布與紫杉醇加安慰劑的對比試驗。無論獲益程度如何，我們都希望透過單一療法在 PFS 中看到類似的益處。

If you're not seeing a PFS benefit, it would be difficult to get an OS benefit, so you got to get both. And I think from an approval standpoint, it's clear in small cell lung cancer you're getting the PFS benefit and most likely an OS. So to answer your question, that would be the threshold to take forward.

如果您沒有看到 PFS 福利，那麼很難獲得 OS 福利，因此您必須同時獲得兩者。我認為從批准的角度來看，很明顯，對於小細胞肺癌來說，您將獲得 PFS 益處，並且很可能獲得 OS。所以回答你的問題，這就是向前邁進的門檻。

On the breast side, there's not a pathway in HER2-positive breast cancer to get approval based on response rate. It's got to be PFS and OS. So I think again we would need to see a PFS in that third-line setting that would be something we would want to invest in and take forward. That would clearly need to be something better than what is being seen with endocrine alone. And again, I think we would again look to most likely try to develop that in biomarker subgroups where the Aurora kinase pathway plays a role.

在乳癌方面，HER2 陽性乳癌尚無基於反應率獲得批准的途徑。它必須是 PFS 和 OS。因此，我再次認為，我們需要在第三線環境中看到 PFS，這是我們想要投資並推進的事情。這顯然需要比單獨透過內分泌檢查所看到的結果更好。再次，我認為我們最有可能嘗試在 Aurora 激酶路徑發揮作用的生物標記亞群中開發它。

And the last part of your question, should any of those fall short, would we immediately go run out and try to bring something else in? No, we probably want to be selective. Look, being a profitable company, we 100% recognize our fiscal responsibility to the shareholders. Spending money on projects that aren't going to result in benefits for patients and hence benefits for shareholders is not something we're looking to do.

你問題的最後一部分是，如果其中任何一個方面不夠完善，我們會立即嘗試引入其他東西嗎？不，我們可能想要有所選擇。你看，作為一家獲利的公司，我們 100% 認識到我們對股東的財務責任。我們不想把錢花在那些不會為患者帶來好處、也不會為股東帶來好處的項目。

Okay, that's helpful. I mean, I was also asking the other direction also as well like if you do meet those bars, next steps in one or two tumor types, is that enough that you maybe wouldn't be very interested in bringing in additional products as well?

好的，這很有幫助。我的意思是，我也在問另一個方向，例如如果你確實達到了這些標準，那麼在一兩種腫瘤類型中採取下一步措施，這是否足夠了，以至於你可能不太有興趣引入其他產品？

Oh, to be honest with you, Marc, look, there's a lot of things out there we could bring in, and to be honest, that's both on the commercial side and on the development side.

哦，老實說，馬克，你看，我們可以引進很多東西，老實說，這既包括商業方面，也包括開發方面。

Having been a profitable company now for three to four years, it allows you to be in control of your own destiny, and I think that's something that we like. And we like having the ability to tell shareholders that we don't need any additional capital, and we have enough to get this -- in our models, we have enough to get alisertib to the market just through our own commercial efforts and investing the profits from NERLYNX in alisertib.

公司已經獲利三到四年了，它讓你掌控自己的命運，我認為這是我們喜歡的。我們很高興能夠告訴股東，我們不需要任何額外的資本，我們有足夠的資金來實現這一目標——在我們的模式中，我們有足夠的資金透過我們自己的商業努力將 alisertib 推向市場，並將 NERLYNX 的利潤投資於 alisertib。

I really wouldn't want to do anything, as we've said in the speech many times, that makes this company unprofitable. That's just not something we would want to do. And that's true both in terms of bringing in additional commercial assets and/or bringing in a development-stage one.

正如我們在演講中多次提到的那樣，我真的不想做任何導致公司無利可圖的事情。這不是我們想做的事。無論是引入額外的商業資產還是引入開發階段的資產，都是如此。

Okay, that's helpful thank you.

好的，這很有幫助，謝謝。

Sure.

當然。

Thank you. This concludes our question-and-answer session. I would like to turn the conference back to Mariann for closing remarks.

謝謝。我們的問答環節到此結束。我想請瑪麗安在會議結束時致閉幕詞。

Thank you all for joining us today. As a reminder, this webcast may be accessed via replay at pumabiotechnology.com beginning later today. Have a good evening.

感謝大家今天的參與。提醒一下，今天稍後開始您可以透過 pumabiotechnology.com 重播觀看該網路廣播。祝您晚上愉快。

Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program. Everyone have a great day. You may now disconnect.

女士們、先生們，感謝你們參加今天的電話會議。我們的節目到此結束。祝大家有個愉快的一天。您現在可以斷開連線。